Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. · ¶20

Hikma responded to these new developments by supplementing its pending ANDA with a section viii statement. Hikma now sought approval of a skinny label that included only the SH indication (no longer protected by a method-ofuse patent). Id., at 1373. To ensure that its labeling otherwise mirrored Vascepa’s, see 21 U. S. C. §355(j)(2)(A)(v) (requiring generic labeling to be the “same” as the brand-name labeling with a few exceptions), Hikma also removed the CV Limitation of Use from its proposed label. In 2020, the FDA approved Hikma’s ANDA with the skinny label, and assigned Hikma’s generic drug an “AB” rating, indicating that it is therapeutically equivalent to Vascepa when used according to its labeling. 104 F. 4th, at 1373–1374.

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